BARRIERFLEX-I, AND BARRIERFLES-II— 510(k) K934189
Substantially EquivalentBird Life Design
FDA 510(k) clearance K934189 for BARRIERFLEX-I, AND BARRIERFLES-II, Substantially Equivalent on 1993-11-24. Applicant: Bird Life Design. Device class: 2.
Clearance details
- Applicant
- Bird Life Design
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dallas, TX, US
Recent devices under product code CAH
view allMore clearances from Bird Life Design
view allAdverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.